European Authorized Representative (EU-REP) service for In Vitro Diagnostic (IVD) devices under IVDR 2017/746. Provides regulatory compliance and market access support for Class A through Class D IVD products, including self-testing devices, across the EU, UK, and Switzerland. ISO 13485 certified wi...
Manufactured by
MedNet EC-REP GmbH
Münster, Germany
With many years of experience and a highly qualified team, MedNet EC-REP offers all services for the pan-European marketing authorization of your products: the European Authorized Representative (EC-REP), the UK Responsible Person (UK RP) and the Swiss Authorized Representative (CH-REP). We specialize in medical devices, in vitro diagnostics (IVD), personal protective equipment (PPE), clinical investigations and performance studies, and application for certificates of free sale (FSC).
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Regulatory consulting and in-country representation services for medical devices and IVDs across EU, UK, Switzerland, USA, and Australia. Enables non-domestic manufacturers to achieve market compliance and maintain regulatory standing in multiple jurisdictions through appointment as Authorized Representative or equivalent legal entity.
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European Authorized Representative and regulatory compliance service for medical devices and IVDs. Provides in-country representation across EU, UK, Switzerland, USA, and Australia to ensure manufacturers meet MDR, IVDR, AI Act, and GDPR requirements.
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Regulatory representation services for medical devices and IVDs under MDR, IVDR, and related frameworks. EC-REP, CH-REP, and PRRC designation support enables market access and compliance across EU and international jurisdictions. Expert guidance on regulatory strategy, documentation, and post-market obligations.
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